RESUMEN
INTRODUCTION: Antibiotic resistance is a growing threat to public health, and antibiotic prescribing increases. About 90% of antibiotics are prescribed in general practice, mostly for acute respiratory tract infections. It is well known that patient expectations and general practitioners' misinterpretation of patients' expectations are associated with antibiotic overuse. The aim of this study was to explore Danish patients' expectations when consulting a general practitioner with symptoms of acute respiratory tract infection, and to determine predictors for these expectations. METHODS: A questionnaire survey was conducted in Danish primary care during 2014. Patients aged ≥ 18 years were asked about their expectations to the consultation when consulting with symptoms of acute respiratory tract infections. Associations between socio-demographic characteristics, self-reported antibiotic prescription and patients' expectations were also explored. RESULTS: A total of 567 patients with symptoms of acute respiratory tract infections were recorded as interested in receiving a questionnaire, 361 of whom responded. The majority expected an examination (94.6%) and an explanation (85.9%). About one third expected antibiotic treatment (32.3%). Patients who expected an antibiotic were more than eight times more likely to be prescribed one than were patients not expecting an antibiotic (odds ratio = 8.6 (95% confidence interval: 4.63-16.03); p < 0.001). CONCLUSIONS: Most Danish patients expected an examination and/or an explanation of their symptoms when consulting with their general practitioner. FUNDING: The study was, in part, funded by The Council for Quality Assurance in Primary Care in both The Region of Southern Denmark and Region Zealand. Malene Plejdrup Hansen received a postdoctoral scholarship in general practice and family medicine from The Novo Nordic Foundation. The sponsors have not been involved in the design or the development of the study. TRIAL REGISTRATION: This study was registered with the Danish Data Protection Agency (R. no. 2013-41-2582).
Asunto(s)
Medicina General/estadística & datos numéricos , Motivación , Prioridad del Paciente/psicología , Derivación y Consulta/estadística & datos numéricos , Infecciones del Sistema Respiratorio/psicología , Adolescente , Adulto , Antibacterianos/uso terapéutico , Dinamarca , Femenino , Humanos , Masculino , Persona de Mediana Edad , Uso Excesivo de Medicamentos Recetados/psicología , Infecciones del Sistema Respiratorio/tratamiento farmacológico , Encuestas y Cuestionarios , Adulto JovenRESUMEN
PURPOSE: Generic switching of warfarin was recently repealed in Denmark, as adverse drug reaction (ADR) reports suggested risk of excessive anticoagulation following switches from branded to generic warfarin. We investigated this putative association in a formalized pharmacoepidemiological analysis. METHODS: We conducted a nationwide cohort study based on Danish healthcare registries, including data from the introduction of generic warfarin until the repeal (January 2011-April 2015). We followed Danish warfarin users over time and compared the rate of incident hospitalizations due to excessive anticoagulation (i.e. increased INR or any bleeding requiring hospitalization) in periods following a recent switch to generic warfarin to the rate in periods without a recent switch. RESULTS: We included 105,751 warfarin users, filling a total of 1,539,640 prescriptions for warfarin (2.5% for generic warfarin). This constituted 89.0% of all warfarin prescriptions in Denmark during the study period. We observed 19,362 switches to generic warfarin during the study period. The adjusted hazard ratio for excessive anticoagulation following a recent switch from branded to generic warfarin was 1.1 (95%CI, 0.8-1.4). The result was robust within subgroups and several sensitivity analyses. CONCLUSION: Switching from branded to generic warfarin is not associated with an increased risk of hospitalization with excessive anticoagulation. However, a minor excess risk of transient INR increase cannot be excluded. Pharmacoepidemiological studies provide an effective method for swift evaluation of hypotheses generated by ADR-reports.
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Sistemas de Registro de Reacción Adversa a Medicamentos/estadística & datos numéricos , Anticoagulantes/efectos adversos , Medicamentos Genéricos/efectos adversos , Hemorragia/epidemiología , Farmacoepidemiología/métodos , Warfarina/efectos adversos , Anticoagulantes/administración & dosificación , Anticoagulantes/uso terapéutico , Estudios de Cohortes , Dinamarca/epidemiología , Medicamentos Genéricos/administración & dosificación , Medicamentos Genéricos/uso terapéutico , Hemorragia/sangre , Hemorragia/inducido químicamente , Humanos , Relación Normalizada Internacional , Warfarina/administración & dosificación , Warfarina/uso terapéuticoRESUMEN
BACKGROUND: Generic substitution means that one medicinal product is replaced by another product containing the same active substance. Generic substitution has existed in Denmark since 1991, and pharmacies are obliged to substitute a generic version of a medication, unless the general practitioner (GP) has explicitly stated that it should not be done, or the patient insists on having the more expensive drug. Generic prescribing, that is prescribing the substance name, is not allowed in Denmark. Some specialists and patients cast doubt on the real interchange-ability of generics, although international studies have shown that most patients have positive attitudes towards generic substitution. The severity of disease is known to be associated with patients being more concerned about generic substitution. The generic substitution scheme implies changing from one drug to another that may vary in brand-name, form, size, colour and taste. Speculations have been raised as to whether these medication changes between generic brands or from brand-name drugs to generics or vice versa may cause patient concerns. Qualitative studies have shown problems in recognising the substituted medicine and lack of confidence in the identical effect of the substitutable medicines. Several studies have focused on one specific drug group such as antihypertensive drugs. However, the influence of generic switching may affect concerns about medicine differently, depending on drug categories. Research on generic substitution often focuses on incident drug users, whose prescription is substituted at their first redemption. Most of these studies did not identify significant associations between generic substitution and non-adherence, but one study assessing the association between generic substitution and persistence showed reduced persistence. So far, studies of the effect of generic drug substitution on drug continuation have not focused on patients' overall experience of generic switches within one specific drug. AIMS: To analyse associations between generic substitution and patient characteristics as well as patients' views on generic medicines, confidence in the healthcare system, beliefs about medicine, and experience with earlier generic substitution. To investigate the possible association between a specific generic switch and patients' concerns about their medicine. To examine how generic switch influences persistence with long-term treatment with special focus on importance of patients' concerns and views on generic medicine. METHODS: The design was a combined cross-sectional questionnaire and register study and additionally a cohort study. The study was conducted among 6,000 medicine users, who had redeemed generically substitutable drugs with general reimbursement in September 2008 (2,000 users of antidepressants, 2,000 users of antiepileptics and 2,000 users of other substitutable drugs), who were aged 20 years or older and living in the Region of Southern Denmark. The medicine users were identified through Odense PharmacoEpidemiologic Database (OPED). The purpose of the questionnaire survey was to elucidate patients' experience with medicine, combined with information from OPED on a single well-defined generic switch of the index drug. The questionnaire was adapted to the individual subject with reference to their specific drug (index drug) in every question and index date printed on the questionnaire. The questionnaire comprises scales from the validated Beliefs about Medicine Questionnaire (BMQ) and ad hoc constructed scales. By means of OPED data it was possible to conduct a cohort study comprising information on all purchased medicine during the 12 months following the index date. The cohort comprised users of antidepressants and users of antiepileptics. RESULTS: A total of 2,476 patients (44.1%) were included in the analyses. Experience with earlier generic switches within the index ATC code was associated with experience of a generic switch on the index day (OR 5.93; 95% CI 4.70-7.49). However, experience with earlier generic switches was drug-specific, e.g. having had more than five earlier switches within other ATC codes reduced the odds of experiencing a generic switch on the index day. Having negative views on generic medicines also reduced the odds of experiencing a generic switch on the index day. The second study showed no statistically significant associations between experiencing a generic switch on the index day and having more or less concerns about the index medicine (-0.02 95% CI: -0.10-0.05). Patients experiencing their first-time switch of a specific drug were at higher risk of non-persistence, hazard ratio 2.98, 95% CI 1.81-4.89, versus those who have never switched, and 35.7% became non-persistent during the first year of follow-up. Generic switching did not influence persistence considerably in those having previous experience with generic switching of the specific drug. CONCLUSION: The overall results from the thesis showed that experience with earlier generic switches of a specific drug was associated with making a future generic switch and did not cause additional concerns about the index medicine. The effect of previous experience with generic substitution has been shown to be drug-specific. The third study showed that patients, who are first-time switchers of a specific drug, were at higher risk of becoming non-persistent compared to never switchers and those having experienced previous generic switching.
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Sustitución de Medicamentos/psicología , Medicamentos Genéricos/uso terapéutico , Satisfacción del Paciente/estadística & datos numéricos , Adulto , Anciano , Anciano de 80 o más Años , Anticonvulsivantes/uso terapéutico , Antidepresivos/uso terapéutico , Estudios de Cohortes , Estudios Transversales , Dinamarca , Femenino , Medicina General , Humanos , Masculino , Persona de Mediana Edad , Encuestas y Cuestionarios , Adulto JovenRESUMEN
BACKGROUND: Generic substitution means that one medicinal product is replaced by another product containing the same active substance. It is strictly regulated with respect to its bioequivalence, and all products must have undergone appropriate studies. Although generic substitution is widely implemented, it still remains to be answered how generic switch influences persistence to long-term treatment, and if it is modified by patients' concerns about medicine and views on generic medicine. This study focuses on users of antidepressants and antiepileptics, and their experience of generic switching. METHODS: The study was an observational cohort study. By use of a prescription database, we identified patients who had redeemed prescriptions on generically substitutable drugs, and a questionnaire was mailed to them. We analyzed predictors of discontinuation in relation to generic switch and patients' attitudes towards generic medicines and concerns about their medicine. RESULTS: Patients who experience their first-time switch of a specific drug were at higher risk of non-persistence, Hazard Ratio 2.98, 95% CI (1.81;4.89) versus those who have never switched, and 35.7% became non-persistent during the first year of follow-up. Generic switching did not influence persistence considerably in those having previous experience with generic switching of the specific drug. Stratified analyses on users of antidepressants and antiepileptics underpin the results, showing higher risk of non-persistence for first-time switchers for both drug categories. CONCLUSION: In conclusion, patients who are first-time switchers of a specific drug were at higher risk of non-persistence compared to never switchers and those having experienced previous generic switching.
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Anticonvulsivantes/uso terapéutico , Antidepresivos/uso terapéutico , Medicamentos Genéricos/uso terapéutico , Adulto , Anciano , Dinamarca , Sustitución de Medicamentos/estadística & datos numéricos , Femenino , Encuestas Epidemiológicas , Humanos , Masculino , Persona de Mediana Edad , Cooperación del Paciente/estadística & datos numéricos , Sistema de Registros , Equivalencia Terapéutica , Adulto JovenRESUMEN
PURPOSE: This study aims to investigate the possible association between patients' concerns about their medicine and generic switch. METHODS: Cross-sectional survey was carried out comprising responses from 2217 randomly selected persons aged 20 years or older and living in the Region of Southern Denmark, who had redeemed generically substitutable drugs in September 2008. For each patient, we focused on the purchase of one generically substitutable drug (index drug). We applied the specific concerns subscale from the Beliefs about Medicine Questionnaire (BMQ) to analyse lack of confidence in treatment. We also included general beliefs about medicine (BMQ), views on generic medicine and confidence in the health-care system. The information about the patients' generic switch was obtained from a prescription database and not provided by the patients. Data were analysed using linear regression. RESULTS: No statistically significant associations were found between concerns about the index medicine and the generic switch (-0.02 95% CI: -0.10; 0.05). Viewing medicines as harmful in general was associated with increased concerns (BMQ general harm: 0.39 95% CI: 0.30; 0.47 and BMQ general overuse: 0.28 95% CI: 0.20; 0.35). Patients having high confidence in the health-care system showed less concern (-0.16 95% CI: -0.27; -0.06). CONCLUSION: This study showed that for all three drug categories investigated, the patients who experienced a generic switch did not have more concerns about their index medicine than patients who did not switch.
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Sustitución de Medicamentos/psicología , Medicamentos Genéricos/uso terapéutico , Aceptación de la Atención de Salud/estadística & datos numéricos , Conocimiento de la Medicación por el Paciente/estadística & datos numéricos , Adulto , Anciano , Estudios Transversales , Bases de Datos Farmacéuticas , Dinamarca , Femenino , Humanos , Modelos Lineales , Masculino , Persona de Mediana Edad , Sistema de Registros , Encuestas y CuestionariosRESUMEN
BACKGROUND: Generic substitution has been implemented in many countries, but knowledge about patients' attitudes, beliefs and experiences is still sparse. AIM: To assess associations between generic switching and patients' attitudes, beliefs and experiences with previous generic switching. DESIGN AND SETTING: A cross-sectional study comprising questionnaire responses from 2,476 randomly selected patients aged 20 years or older and living in the Region of Southern Denmark, who had redeemed substitutable drugs. METHODS: The questionnaire included items on beliefs about medicine, views on generic medicine and confidence in the healthcare system. Only prescriptions issued by the general practitioners were included. For each patient, we focused on one purchase of a generically substitutable drug (index drug). Patients were identified by means of a dispensing database. RESULTS: Earlier generic switches within the index ATC code were statistically significantly associated with experience of a generic switch (adjusted OR 5.93; 95 % CI 4.70-7.49). Having had more than five earlier switches within other ATC codes and having negative views on generic medicines reduced the odds of experiencing a generic switch. No associations were found between generic substitution and gender, drug group, number of different drugs used by the patient, confidence in the health care system and beliefs about medicine in general. CONCLUSION: Patients who had once experienced a generic switch were more likely to accept a future generic switch within the same ATC code. Negative views on generic medicines were negatively associated with switching, while beliefs about medicine and confidence in the healthcare system had no influence.